Pilot Study of Ultrasound in Rheumatoid Arthritis
A Pilot Study of Musculoskeletal Ultrasound Assessment in Patients With Rheumatoid Arthritis
Little is currently known as to the predictive value of ultrasound in guiding the decision to taper drug treatment in patients with stable rheumatoid arthritis, nor the influence that patients' views and opinions regarding their medications may have upon this. In this study, patients with stable rheumatoid arthritis will undergo a simple examination of their joints to look for any swelling or tenderness followed by an ultrasound scan to look for joint inflammation. Half of the patients will also complete an interview to assess their views and opinions of arthritis drug treatment. The study will be completed in a single patient visit - no invasive tests will be performed, and no changes to treatment will be made.
This study is being conducted as part of a Masters degree from Newcastle University. The results of this study will be used to inform the feasibility of inclusion of ultrasound assessment within the design of a future PhD study to investigate potential markers of remission in patients with rheumatoid arthritis.
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Newcastle upon Tyne、イギリス、NE7 7DN
- Musculoskeletal Outpatient Department, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Diagnosis of rheumatoid arthritis with symptom onset at least 12 months previously
- Current disease-modifying anti-rheumatic drug (DMARD) therapy or biologic therapy
- Currently stable arthritis defined as no change in DMARD treatment over previous 6 months, and no use of steroids (enteral, parenteral or intra-articular) over previous 6 months
Exclusion Criteria:
- Inability to provide informed consent
- Current or recent (within 4 months) participation within another clinical trial
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
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Observational study group
Musculoskeletal ultrasound (all patients) and semi-structured patient interview (anticipated maximum 15 patients)
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7-joint musculoskeletal ultrasound scan
Semi-structured patient interview
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Evidence of reliability of intra- and inter-rater ultrasound agreement for power Doppler synovitis score
時間枠：At recruitment
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Defined as Kappa statistic of at least 0.4.
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At recruitment
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Qualitative data relating to patients' views and opinions of their arthritis medication
時間枠：At recruitment
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Based upon data collected by a semi-structured interview approach and analysed using standard qualitative techniques.
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At recruitment
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Simplified Disease Activity Index (SDAI)
時間枠：At recruitment
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At recruitment
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Disease Activity Score in 28 joints (DAS-28)
時間枠：At recruitment
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At recruitment
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Disease Activity Score (DAS)
時間枠：At recruitment
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At recruitment
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協力者と研究者
捜査官
- 主任研究者：John D Isaacs, PhD, MB BS、Newcastle University
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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